Identity
- Trade Name
- Proxeo ULTRA Handpiece PB-5 L FDA UDI
- Generic Name
- Dental ultrasonic surgical system handpiece FDA UDI
- Device Name
- Handpiece for Proxeo ULTRA FDA UDI
- Model / Reference
- 30326000 FDA UDI
- Description
- Handpiece for Proxeo ULTRA FDA UDI
Identifiers
- Primary DI / UDI-DI
- J021303260001 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Dental ultrasonic surgical system handpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental ultrasonic surgical system handpiece
Proxeo ULTRA Handpiece PB-5 L by W & H Dentalwerk Bürmoos GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental ultrasonic surgical system handpiece.
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- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- ACTEON — Satelec · Class II
- PIEZON — E.M.S. Electro Medical Systems S.A. · Class II
- MECTRON — MECTRON SPA · Class I
- MECTRON — MECTRON SPA · Class II
- Johnson-Promident — Young Innovations, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- W & H Dentalwerk Bürmoos GmbH
Sources (1)
- FDA UDI 6101dc54-d9fd-4ea5-84e0-e29f6b58cbb7 33 fields · synced May 30, 2026